A Pharmacokinetic/Pharmacodynamic Study of RO5185426 in Previously Treated Patients With Metastatic Melanoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01107418
First received: April 12, 2010
Last updated: March 3, 2014
Last verified: March 2014

April 12, 2010
March 3, 2014
May 2010
February 2013   (final data collection date for primary outcome measure)
Pharmacokinetics: RO5185426 plasma concentration [ Time Frame: multiple sampling days 1, 2, 9, 11, 15, 16 and 18; and on day 1 cycles 1-8 and every other cycle starting cycle 9 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01107418 on ClinicalTrials.gov Archive Site
  • Safety and tolerability: Incidence of adverse events (AEs) [ Time Frame: throughout study ] [ Designated as safety issue: No ]
  • Safety and tolerability: Assessment of routine laboratory values [ Time Frame: laboratory assessments every 3 weeks ] [ Designated as safety issue: No ]
  • Efficacy: Best overall response (OR) [ Time Frame: tumor assessments every 2 cycles ] [ Designated as safety issue: No ]
  • Efficacy: Overall survival (OS) [ Time Frame: event driven, assessed at study completion ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Pharmacokinetic/Pharmacodynamic Study of RO5185426 in Previously Treated Patients With Metastatic Melanoma
A Phase I, Randomized, Open-label, Multi-center, Multiple Dose Study to Investigate the Pharmacokinetics and Pharmacodynamics of RO5185426 Administered as 240 mg Tablets to Previously Treated BRAF V600E Positive Metastatic Melanoma Patients

This open-label study will assess the pharmacokinetics, efficacy and safety of RO5185426 administered as 240mg tablets in previously treated patients with metastatic melanoma. Patients will be randomized to receive one of four dose-levels of RO5185426 [RG7204; PLEXXIKON; PLX4032] orally twice daily on days 1 to 15 (morning dose). Starting on day 22, treatment with RO5185426 may be resumed at a dose of 960 mg twice daily and continued until disease progression. Target sample size is <100 patients.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Malignant Melanoma
  • Drug: RO5185426
    dosage b) orally twice daily, days 1-15 (morning dose)
  • Drug: RO5185426
    dosage c) orally twice daily, days 1-15 (morning dose)
  • Drug: RO5185426
    dosage d) orally twice daily, days 1-15 (morning dose)
  • Drug: RO5185426
    960 mg orally twice daily, from day 22 onward
  • Drug: RO5185426
    dosage a) orally twice daily, days 1-15 (morning dose)
  • Experimental: 1
    Interventions:
    • Drug: RO5185426
    • Drug: RO5185426
  • Experimental: 2
    Interventions:
    • Drug: RO5185426
    • Drug: RO5185426
  • Experimental: 3
    Interventions:
    • Drug: RO5185426
    • Drug: RO5185426
  • Experimental: 4
    Interventions:
    • Drug: RO5185426
    • Drug: RO5185426

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
February 2013
February 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients, >/=18 years of age
  • histologically confirmed metastatic melanoma, stage IIIc or IV (AJCC)
  • failure of at least one prior standard of care regimen
  • positive for BRAF V600E mutation (by Roche CoDx BRAF mutation assay)
  • ECOG performance status 0 or 1
  • adequate hematologic, renal and liver function

Exclusion Criteria:

  • active CNS lesions on CT/MRI within 28 days prior to enrollment
  • history of spinal cord compression o carcinomatous meningitis
  • anticipated or ongoing anti-cancer therapies other than those administered in this study
  • previous treatment with BRAF inhibitor (sorafenib allowed) or MEK inhibitor
  • severe cardiovascular disease within 6 months prior to study
  • previous malignancy within the past 5 years except for basal or squamous cell carcinoma of the skin, melanoma in-situ and carcinoma in-situ of the cervix
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia
 
NCT01107418
NP25163
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP